Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication

NCT ID: NCT06583005

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2027-05-15

Brief Summary

The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.

Conditions

Parkinson Disease, Idiopathic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stimulation

Participants will stimulate with the device, called the Stanford CR glove, on a daily or weekly basis depending on their progress through the study procedures. The device itself is a glove that is designed to deliver vibrations to the fingertips of each hand.

Group Type: EXPERIMENTAL

Vibrotactile Coordinated Reset

Intervention Type: DEVICE

The Stanford CR glove is designed to administer vibrotactile coordinated reset stimulation, which consists of vibratory stimulation of the fingertips delivered in a specific pattern which is design to disrupt and normalize abnormal brain synchrony.

Interventions

Vibrotactile Coordinated Reset

The Stanford CR glove is designed to administer vibrotactile coordinated reset stimulation, which consists of vibratory stimulation of the fingertips delivered in a specific pattern which is design to disrupt and normalize abnormal brain synchrony.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age at the time of enrollment: Adults 18 and older
• Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
• Fluent in English
• Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
• Lives in the United States

Exclusion Criteria

• Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
• Any current drug or alcohol abuse.
• Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
• Pregnancy, breast-feeding or wanting to become pregnant.
• Patient is unable to communicate properly with staff (i.e., severe speech problems).
• Excessive drooling

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Vivek P. Buch

Assistant Professor of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jessica Yankulova

Role: CONTACT

jessky@stanford.edu

‭(650) 474-9547‬

Ellyn Daly

Role: CONTACT

ellynd@stanford.edu

(650) 313-8775

Other Identifiers

75389

Identifier Type: -

Identifier Source: org_study_id